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Side Effects & Adverse Reactions
This product should be used with care in cases of long-standing otitis media because of the possible perforation of the eardrum concomitant with the external ear use of this product. This preparation is not intended for opthalmic or oral use. If irritation or sensitization occurs, promptly discontinue use of this preparation and institute other measures.
Legal Issues
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FDA Safety Alerts
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Manufacturer Warnings
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FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
For the treatment of superficial infections of the external ear caused by microbes, and to control the accompanying inflammation and itching.
History
There is currently no drug history available for this drug.
Other Information
Oto-End 10 Ear Drops is an anti-inflammatory, antimicrobial and local anesthetic solution for use in the external ear only.
Each 1 mL for otic administration contains:
Hydrocortisone . . . . . . . . . . . . . . 10 mg
Pramoxine Hydrochloride . . . . . . 10 mg
Chloroxylenol . . . . . . . . . . . . . . . . 1 mg
Hydrocortisone (cortisol) is an anti-inflammatory and antipruritic agent. It is a white to practically white, odorless, crystalline powder, very slightly soluble in water. It has the chemical name Pregn-4-ene-3,20-dione, 11,17,21-trihydroxy-,(11β)- and the following structural:
C 21H 30O 5
M.W. 362.46
Pramoxine hydrochloride is a topical anesthetic. Used as the hydrochloride salt, it has the chemical name Morpholine, 4-[3-(4-butoxyphenoxy)propyl]-, hydrochloride.
C 17H 27NO 3 • HCl
M.W. 329.86
Chloroxylenol (4-chloro-3, 5-dimethyl phenol or meta-chloro-xylenol) is a wide spectrum antimicrobial agent. It has the following structural formula.
C 8H 9ClO
M.W. 156.61
Sources
Medi-first Eyewash Manufacturers
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Unifirst First Aid Corporation
Medi-first Eyewash | Larken Laboratories, Inc.
The external ear, that is the auricle and the auditory canal should be thoroughly cleansed and dried. Four (4) to 5 drops of Oto-End 10 Ear Drops should be instilled into the affected ear 3 or 4 times daily. For infants and small children, 3 drops are suggested because of the smaller capacity of the ear canal. The patient should lie with the affected ear upward to instill the drops and this position maintained for 5 minutes to facilitate penetration of the drops into the ear canal. Repeat, if necessary for the opposite affected ear. If preferred, a gauze ear plug or a wick may be inserted into the ear canal prior to applying Oto-End 10 Ear Drops. When using a wick, a few drops of sterile water should be applied directly to the wick following insertion to facilitate hydration. It should then be saturated with Oto-End 10 Ear Drops. The patient should be instructed to add a few drops of Oto-End 10 Ear Drops to the wick every four hours, and to remove the wick after 24 hours. Five (5) drops of Oto-End 10 Ear Drops should be instilled 3 or 4 times daily thereafter. When using a gauze ear plug, the external ear canal is first treated with drops of Oto-End 10 Ear Drops. Next, the gauze is inserted into the ear canal to contain the medication. The gauze ear plug or the expanded wick are easily removed using fingers, forceps, or tweezers. This product may be used in the unaffected ear 3 times daily as a preventative.
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